R59- GERN
Re, I did quite a bit of homework on finding out how often and why the FDA goes against the advisory committee. Turns out, around 20% of the time, the FDA goes against the advisory committee. However only 15% of the time when the committee is positive, ie was with GERN. Now of that 15%, the deciding factor was generally when the board was not in consensus, which was not the case with GERN 12 to 2 vote. So basically, if we narrow it down, the FDA gives approval around 95% of the time the Advisory Committee is consensus positive. So that leaves us with around 5% of the time, and that's generally when the FDA has serious safety concerns, which I must say they did with GERN.
I just wanted to ask you, do you think the FDA will find not to approve GERN. I mean the FDAs view was basically that the side effects of GERNs drug Imetelstat didn't overcome the benefits of the drug. However one doctor after another on the advisory board told the FDA that they think the drug benefits are much greater than the FDA gave credit for, and that the cytopenias side affects can be well managed and is often transient. Re, I was, and still am astounded at how negative the FDA was in it's opening remarks last Thursday. I mean they basically said they don't think GERNs drug works very well, and that the side effects don't overcome the very slight benefit.. Again, one doctor after another came out to disagree with the FDA, and point out that it's transfusion independence, and not disease modification that is they use to judge how much benefit the drug has- and they felt Imetelstat had tremendous benefit with the fact that 41% of the resondents had transfusion independence, with 75% of them having this for 51 weeks, and that hemoglobin levels were significantly higher as well. Re, after listening to the entire ADCOM presentation last Thursday, it sure seems that the FDA had it out for GERN, and again, I'm astounded at the disconnect between the advisory boards views and the FDAs.
